NCT03003715

Brief Summary

The main goal of this study to integrate techniques producing images of the brain (also called neuroimaging techniques) with non-invasive brain stimulation to investigate factors that may be associated with chronic pain in patients with Trigeminal Neuropathic Pain (TNP).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
Last Updated

November 24, 2017

Status Verified

November 1, 2017

Enrollment Period

1.3 years

First QC Date

December 22, 2016

Last Update Submit

November 21, 2017

Conditions

Trigeminal Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

  • Change in MOR BPND levels

    change from baseline to versus sham or active tDCS

    place weeks after not more than 6months

Study Arms (2)

Refractory Trigeminal Neurpathic Pain (TNP) Patients

EXPERIMENTAL

All patients receive QST prior to PET scan used to obtain baseline measures, then placebo tDCS, followed by QST and Active tDCS, over the course of a 90 minute PET scan; QST is used again to take final measurements 30 minutes later.

Procedure: PET ScansProcedure: transcranial direct current stimulation (tDCS)Procedure: MRIOther: sham tDCS (prior to real tDCS)

Healthy volunteers

EXPERIMENTAL

All volunteers receive QST prior to PET scan used to obtain baseline measures, then placebo tDCS, followed by QST and Active tDCS, over the course of a 90 minute PET scan; QST is used again to take final measurements 30 minutes later.

Procedure: PET ScansProcedure: transcranial direct current stimulation (tDCS)Procedure: MRIOther: sham tDCS (prior to real tDCS)

Interventions

PET ScansPROCEDURE

Two 90 minute scans whose maximum radiological dose is 15 mCi \[11 C\] carfentanil, a selective and specific mu-opioid receptor radioligand. The first one provided baseline data, and the second occurred with the sequence of sham tDCS and tDCS as described in each arm description.

Healthy volunteersRefractory Trigeminal Neurpathic Pain (TNP) Patients
transcranial direct current stimulation (tDCS)PROCEDURE

In active tDCS, a 2 milli-amp transcranial direct current stimulation is for 20 minutes.

Healthy volunteersRefractory Trigeminal Neurpathic Pain (TNP) Patients
MRIPROCEDURE

No radiotracer is used; 3 tesla scanner; all participants have MRI prior to PET scans.

Healthy volunteersRefractory Trigeminal Neurpathic Pain (TNP) Patients
sham tDCS (prior to real tDCS)OTHER

For sham tDCS, current is applied only for 30 seconds, as sensations arising from tDCS treatment occur only at the beginning of application; however the equipment will be on the participant for 20 minutes to match that of the active tDCS application.

Healthy volunteersRefractory Trigeminal Neurpathic Pain (TNP) Patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Daily chronic TNP for at least 6 months not adequately controlled by pervious medicine therapies;
  • minimal average baseline pain score of 4 (moderate to severe) in the visual analogue scale (VAS);
  • unilateral pain
  • orofacial allodynic region to mechanical (light touch or palpation) or thermal stimulation (head or cold);

You may not qualify if:

  • pregnancy or planning to become pregnant
  • local pathology (e.g. orofacial lesion)
  • history of systemic disorders (e.g. MS)
  • history of other chronic pain disorder (e.g. back pain)
  • recent orofacial surgery or trauma (\< 6 months)
  • history of central origin disorders (e.g. stroke)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Magnetic Resonance SpectroscopyTranscranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesElectric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Alexandre F DaSilva, DMedSci

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, D.Med.Sc.

Study Record Dates

First Submitted

December 22, 2016

First Posted

December 28, 2016

Study Start

September 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

November 24, 2017

Record last verified: 2017-11

Locations

US(1)